A Randomised, Double-Blind, Active Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Manualised Psychotherapy in Australian War Veterans with Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)
Double-blind, randomised Phase II pilot study (n=14; includes 2-person open-label lead-in) comparing two MDMA-assisted psychotherapy sessions (125 mg vs 30 mg active placebo) plus 10 non-drug psychotherapy sessions in Australian war veterans with chronic, treatment-resistant PTSD.
Details
Randomised, double-blind Phase II pilot: Stage 1 compares full-dose MDMA (125 mg with optional 62.5 mg supplement) versus a low-level active placebo (30 mg with optional 15 mg supplement) delivered as two supervised drug-assisted psychotherapy sessions within a 12-session manualised program.
Treatment comprises two ~8-hour drug sessions spaced 3–5 weeks apart plus 10 non-drug psychotherapy sessions (preparatory, integrative and follow-up). An open-label lead-in (n=2) verifies therapist adherence; Stage 2 offers optional open-label full-dose treatment to eligible participants initially receiving active placebo.
Primary outcome: change in CAPS scores; secondary outcomes include BDI-II and 12-month follow-up assessments.